FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1278079
·
Received November 21, 2008
Report
- Report Number
- 1119421-2008-00939
- Event Type
- Other
- Date Received
- November 21, 2008
- Date of Event
- September 26, 2008
- Report Date
- October 22, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- MJP
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 10/24/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/03/2008.
Description of Event or Problem · 1
A SURGEON REPORTS A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD. | SN60T5 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | VIGAMOX| BSS| DUOVISC| NEVANAC| OMNIPRED |